By Can Cui*
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The 1952 Patent Act sets forth four categories of subject matter that are patent-eligible: process, machine, manufacture, and composition of matter.[FN1] The Supreme Court has interpreted the subject-matter eligibility to be very broad[FN2]; instead of delineating what is patent-eligible, the Supreme Court has crafted a number of categories of “patent-ineligible” subject matter.[FN3] These judicially crafted categories, however, are not well defined. The boundaries of these categories are also constantly challenged by the advancement of science and technology, particularly biotechnology. While the Patent Act has remained largely unchanged since its codification in 1952, the discovery of the structure of deoxyribonucleic acid (“DNA”) in 1953 has revolutionized our lives in a great number of ways. The complete mapping of the human genome has also changed our way of thinking about life and dealing with disease. Discoverers of new genes, especially those associated with disease susceptibilities, rushed to the patent office to protect their discoveries. Whether DNA molecules should be patented had been the topic of active policy debate for more than twenty years until the early 2000’s, when the question about their subject-matter eligibility was first seriously raised in the academy.[FN4]
On March 29, 2010, in a 156-page-long decision, the U.S. District Court in the Southern District of New York held that claims directed to isolated DNA molecules were invalid under 35 U.S.C. § 101 for failing to claim patent-eligible subject matter, because the claimed isolated DNA molecules were not “markedly different” from native DNA molecules as they exist in nature, according to Senior Judge Robert W. Sweet.[FN5] This Note discusses the patent-eligibility of the subject matter set forth in these DNA-molecule claims.
In determining that these claims-in-suit were invalid under 35 U.S.C. § 101, Judge Sweet first analyzed the scope of § 101, focusing heavily on the so-called “product of nature” doctrine.[FN6] He then reviewed Supreme Court cases and some lower court opinions that are purportedly related to the “product of nature” doctrine, and provided a test for determining whether a product purified from nature is patent-eligible: “the purified product must possess ‘markedly different characteristics’ in order to satisfy the requirements of § 101.”[FN7] Finally, Judge Sweet applied this test to the subject matter in the claims-in-suit. Focusing almost exclusively on “DNA’s unique qualities as a physical embodiment of information,” Judge Sweet concluded that “none of the structural and functional differences cited by [defendant] Myriad between native BRCA1/2 DNA and the isolated BRCA1/2 DNA claimed in the patents-in-suit render[ed] the claimed DNA ‘markedly different’” from its naturally-occurring counterpart, thus failing the test.[FN8]
Needless to say, the outcome of this case, if upheld upon appeal, would have a profound impact on the biotechnology industry. This Note, however, does not try to delve into any policy arguments, but will focus on the more fundamental question about the “product of nature” doctrine, how it has been applied to different types of claimed subject matter prior to Judge Sweet’s opinion, and what an appropriate test should be for applying the doctrine to claims directed to molecules. This Note will propose such a test and apply the proposed test to the DNA-molecule claims-in-suit, leading to a legal conclusion contrary to that of Judge Sweet. This Note will also make an effort to address certain issues in Judge Sweet’s opinion, and to provide some practical tips to patent practitioners in drafting DNA molecule claims.
A. The “Product of Nature” Doctrine: Does It Really Have a Legal History?
Is there a “product of nature” doctrine? At the very least, it is fair to say that the doctrine has not been articulated very well by courts. Judge Sweet cited four cases in which “product of nature” or “products of nature” was recited, none of which has a claim-in-suit directed to a molecule.[FN9] Because the subject matter of the claims-in-suit in Myriad is DNA molecules, this Note will include judicial treatment of molecule claims in the history review of relevant case law in the context of the “product of nature” doctrine. Instead of a chronological order, this Note will apply a brand new analytical framework to the history review, categorizing the relevant cases based on whether the claimed subject matter is an element, a molecule, or a microorganism.[FN10]
1. Naturally-occurring chemical elements are generally patent-ineligible subject matter.
One of the earliest cases ever mentioning a “product of nature” is Gen. Elec. Co., where a claim-in-suit is directed to “[s]ubstantially pure tungsten having ductility and high tensile strength.”[FN11] Even though pure tungsten as claimed had not been found in nature, the Third Circuit’s view was that since tungsten is an element, all of its properties are natural by definition.[FN12] Judge Sweet cited this case to prove the “well established” “product of nature” doctrine.[FN13] One sentence from this case is, however, particularly relevant and worthy of analysis: “a patent cannot be awarded for a discovery or for a product of nature, or for a chemical element.”[FN14] First, the second “or” suggests that the patent-ineligibility of a product of nature is dicta, because the opinion is about the patent-ineligibility of a chemical element, tungsten. Second, the patent-ineligibility of a discovery expressed in this sentence makes the entire sentence susceptible to constitutional attack.[FN15]
The patent-ineligibility of naturally-occurring chemical elements was followed by the Court of Customs and Patent Appeals, which seemed to have more readily relied on the “product of nature” doctrine in its decisions.[F16]
2. Claims to molecules, including those to DNA molecules, had never been invalidated by courts under the “product of nature” doctrine before Judge Sweet’s opinion.
Somewhat surprisingly, case law on the patent-eligibility or –ineligibility of molecules does not prove to be abundant. The only case from the Supreme Court that touched on the issue was decided in 1884, where a claim to a molecule was found invalid based on lack of novelty.[FN17] Similarly, molecule claims were often not attacked before lower courts under the “product of nature” doctrine, but simply for alleged lack of novelty[FN18] or for obviousness.[FN19] One case, Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4th Cir. 1958), specifically mentioned the “product of nature” doctrine. There, the claimed “composition comprising recovered elaboration products” (emphasis added) was found to be patent-eligible because it “did not exist in nature in the form in which the patentees produced it.”[FN20]
Of particular relevance to claims to DNA molecules are two Federal Circuit cases decided in the last decade of the 20th century. In Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F. 2d 1200 (Fed. Cir. 1991), the Federal Circuit held that a claim directed to “[a] purified and isolated DNA sequence” was novel and thus valid.[FN21] Subject matter patent-eligibility was not an issue in this case. Nine years later, the Federal Circuit accepted a district court’s interpretation of “substantially pure DNA sequences” in a patent claim as including “both naturally-occurring and non-naturally occurring sequences.”[FN22] This was an affirmance of a summary judgment of non-infringement, however, and so validity was not an issue in this case at all.
3. Microorganisms: Few but highly relevant cases.
The Supreme Court has thus far taken up only two cases where patent claims reciting microorganisms came under its scrutiny. In Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the Supreme Court held that a product claim directed to “[a]n inoculant . . . comprising a plurality of selected . . . strains of different species of bacteria” did not “disclose an invention or discovery within the meaning of the patent statutes.”[FN23] The opinion did not recite “product of nature,” however, and Justice Douglas’ analysis deserves a closer look. First, the “product” claim-in-suit was not directed to a single bacterial species, but to a composition comprising a plurality of species, which do not co-exist in nature in the form in which they are found in the claimed composition.[FN24] Second, what rendered the product patent-ineligible was not the bacterial species per se, and Justice Douglas did not exclude them from being patent-eligible.[FN25]
Thirty-two years later, the Supreme Court recognized the patent-eligibility of a genetically-engineered bacterium in Chakrabarty. The claimed bacterium was a new strain of Pseudomonas into which two stable energy-generating plasmids[FN26] had been introduced to give the bacterium enhanced “hydrocarbon degradative” properties.[FN27] Chakrabarty confirmed the patent-eligibility of what Justice Douglas did not exclude as being patent-ineligible in Funk Bros., i.e., a new bacterium, a changed bacterium, or a bacterium with improved functioning beyond its natural functioning.[FN28] Chakrabarty does not recognize Funk Bros. as good law because of the “product of nature” doctrine, however, because Funk Bros. does not articulate the doctrine and the claimed subject matter in Funk Bros. is not a product of nature.[FN29]
B. A Critique of Judge Sweet’s Test and the Proposal of a New Test.
Judge Sweet readily took one sentence out of Chakrabarty and formulated the “markedly different characteristics” [FN30] test. What led Judge Sweet to reach the conclusion of patent-ineligibility of the claimed DNA molecules is not the lack of markedly different characteristics between them and their naturally-occurring counterparts, however, but some overwhelmingly identical function between them – the function of DNA as genetic information carrier.[FN31] This categorical exclusion of all differences in light of one common function is not the correct approach, however, because where subject matter patent-eligibility is an issue, there is almost always more similarity than difference between the claimed subject matter and its naturally-occurring counterpart. Judge Sweet’s test is also inherently difficult to apply because there is no bright line between a difference that is marked and a difference that is not.
Taking for granted that the “product of nature” doctrine exists, this Note proposes a two-part test in determining subject matter patent-eligibility of molecules under the doctrine. This test puts structure before function, because the latter is at least in part determined by the former. Under this test, the first step is to determine whether there is any structural difference between the claimed molecule(s) and its naturally-occurring counterpart(s) in the absence of any isolation or purification. If a structural distinction is found, the entire analysis is complete. Because of the structural difference, the claimed molecule, by definition, is not a “product of nature,” and is thus patent-eligible. If a claimed molecule has the same structure as its naturally-occurring counterpart in the absence of any isolation or purification, then the next step is to determine whether there is any functional difference between the two. Only a functional difference which would not have existed “but for” the isolation or purification puts the claimed molecule outside the scope of “product of nature.” If the claim passes both parts of the test, i.e., the claimed molecule is structurally identical to its naturally-occurring counterpart and there is no functional difference between the two which would not have existed but for the isolation or purification, then the claimed molecule is a product of nature and patent-ineligible.
C. Application of the Proposed Test Would Have Yielded Results Consistent with the Vast Majority of Relevant Case Law on Molecule Claims.
Retroactive application of the proposed test to molecule-claim case law would have yielded results consistent with the vast majority of relevant cases. For example, the claim in Cochrane would have been found invalid if the “product of nature” doctrine were forced upon it and the proposed test applied, because it would likely have passed both parts of the test, i.e., the claimed molecule is structurally no different from and is used for exactly the same purpose as its naturally-occurring counterpart in the absence of any isolation or purification – as a red dye. In both Parke-Davis and Kuehmsted, the product claims-in-suit could not have been invalidated under the “product of nature” doctrine because the products claimed were structurally different from anything found in nature. In In re Williams, the validity of the product claim-in-suit would have been upheld, too, if the proposed test were applied. Structurally, the claimed molecule, the laevo rotary form of lactone, is different from its naturally-occurring counterpart, which is in racemic form. Even if one could argue that the racemic form necessarily contains the laevo form, the laevo form has a drastically and noticeably different function from the racemic form, which would not have existed but for the purification of it from the racemic form.[FN32]
The only case where the claims-in-suit are true molecule claims and application of the proposed two-part test may have yielded a result inconsistent with the decision of the court is In re Bergstrom. In this case, the claimed PGE2 and PGE3 molecules are structurally no different from their respective naturally-occurring counterparts, and there is no evidence of any functional difference between the claimed molecules and the naturally-occurring molecules either.[FN33] The reason for the inconsistent results does not lie in the proposed test, however, but in the court’s belief that compounds that “do not exist in nature in pure form” are not “naturally occurring.”[FN34] As some of the most fervent proponents of the “product of nature” doctrine clearly pointed out, In re Bergstrom was “not a section 101 patentable subject matter case.”[FN35]
The proposed test is applicable specifically to molecule claims and should not be used on claims directed to elements, because an element, when in pure form (assuming that it does not exist in nature in such pure form), can have very different functions from its status as part of a molecule, and so would have been patent-eligible under the test.[FN36] The inapplicability of the proposed test to element claims is of no significance to patent applicants today, however, because all naturally-occurring elements have been identified by now.
It is also hard to apply the proposed test to claims directed to microorganisms, because microorganisms are so complex that it is meaningless to define if two are “structurally” the same. For now, Chakrabarty has made some bright-line rules, i.e., a difference as large as a few exogenous plasmids would make a new bacterium. It remains to be seen if any smaller difference, e.g., only one exogenous plasmid, or addition or deletion of genomic DNA sequences, or even one or more point mutations, would distinguish a bacterium from its naturally-occurring counterpart under the “product of nature” doctrine.
D. Application of the Proposed Test to the Composition Claims-in-Suit Yields a Legal Conclusion Contrary to That of Judge Sweet’s.
The proposed test can be easily applied to the DNA molecule claims-in-suit in Myriad. The claimed DNA molecules are patent-eligible because they are all structurally different from their naturally-occurring counterparts, i.e., the chromosomes on which BRCA1 and BRCA2 genes are located.[FN37]. Such structural differences are at least two-fold. First, the sequences of the claimed DNA molecules are different from the sequences of the respective chromosomes. For example, the specification defines “isolated DNA,” which is recited in all composition claims-in-suit, as follows: “An ‘isolated’ . . . DNA . . . is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins.”[FN38] In the case of DNA, only other sequences on the same chromosome as a certain native sequence are considered naturally accompanying that native sequence. When a DNA molecule comprises the native sequence substantially separated from the naturally accompanying sequences, such DNA molecule cannot have the same sequence as the chromosome on which the native sequence is located.
Second, the claimed DNA molecules do not contain intron sequences that are parts of the chromosomes. Judge Sweet argues that because native, intron-containing DNAs by definition encode the BRCA1 and BRCA2 proteins, such claims as Claim 1 of the ’282 Patent and Claim 1 of the ’492 Patent read on the native DNAs and so the claimed DNAs are patent-ineligible.[FN39] This argument indeed has some merit with regard to Claim 1 of the ’282 Patent. In contrast to that claim, the distinction between molecule and sequence in Claim 1 of the ’492 Patent helps the patentee obviate such an attack. Native, intron-containing chromosomal DNA falls outside the scope of this claim because even though it encodes the recited polypeptide, the polypeptide is not encoded by a single nucleic acid sequence as required by the claim but collectively by a number of distinct exon sequences interspersed by the introns. This claim represents an excellent example of how careful claim drafting can obviate a “product of nature” rejection.
The claimed DNA molecules are also patent-eligible because there exist functional differences between them and their naturally-occurring counterparts, the chromosomes, which would not have existed but for the isolation. Defendant Myriad focused on the gain of function as a result of the isolation.[FN40] The isolation also causes loss of function, e.g., the isolated DNAs no longer encode, let alone express, the hundreds of genes other than BRCA1 and BRCA2 expressed by their respective chromosomes. Neither the gain of function nor the loss of function would have existed but for the isolation. Therefore, the claimed DNA molecules are not products of nature and are patent-eligible.
The legal history of the “product of nature” doctrine is messy, if not extremely thin. This Note at the outset reviewed judicial opinions on the patent-eligibility and –ineligibility of various claimed subject matter related to the “product of nature” doctrine. Of particular relevance to the DNA molecule claims in the patents-in-suit in Myriad are those cases in which the claims-in-suit were directed to molecules. Significantly, not even one molecule claim was invalidated by courts under the “product of nature” doctrine before Judge Sweet’s opinion.
Assuming the existence of the “product of nature” doctrine, this Note proposed a two-part test applicable to claims directed to molecules that would have unified the holdings of relevant case law and yielded results consistent with them, with one justified exception.[FN41]
Applying the proposed test to the composition claims-in-suit in Myriad leads to only one legal conclusion – the claimed DNA molecules are not products of nature and are patent-eligible. The key to the successful understanding and application of the proposed test is to know what the naturally-occurring counterpart is. The Myriad court compared the sequences of the claimed molecules with certain sequences on the chromosomes. Such comparison is fundamentally flawed. When the claimed subject matter is a molecule, its naturally-occurring counterpart must also be a molecule, not part of a molecule, e.g., a partial sequence of a DNA molecule.
Judge Sweet’s opinion has also been objected to by a wide array of educational institutions and companies in the biotech and the pharmaceutical industries, as evidenced by the vast majority of the amicus briefs filed before the Federal Circuit that are in support of reversal. This Note did not focus on analyzing those briefs. Rather, this Note proposed a test that can be applied to molecule claims under the “product of nature” doctrine and unify the vast majority of relevant case law. The proposed test can, hopefully, draw some bright line in judicial determination of the patent eligibility of molecules.
* B.Sc., Peking University; Ph.D., Harvard University; J.D. candidate, New York University.
[FN1] 35 U.S.C. § 101.
[FN2] J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 124, 131 (2001).
[FN3] See, e.g., Gottschalk v. Benson, 409 U.S. 63, 67 (1972) (“Phenomena of nature, . . . mental processes, and abstract intellectual concepts are not patentable . . . .”); Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (“The laws of nature, physical phenomena, and abstract ideas have been held not patentable.”).
[FN4] See John M. Conley & Roberte Makowski, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (Part I), 85 J. Pat. & Trademark Off. Soc’y, 301 (2003) [hereinafter Conley & Makowski, Back to the Future (I)]; John M. Conley & Roberte Makowski, Back to the Future: Rethinking the Product of Nature Doctrine as a Barrier to Biotechnology Patents (Part II), 85 J. Pat. & Trademark Off. Soc’y, 371 (2003) [hereinafter Conley & Makowski, Back to the Future (II)]. Those articles discuss the patent-eligibility of “genes” and “DNA sequences.” See, e.g., Conley & Makowski, Back to the Future (I), supra, at 309. “Gene patenting” is simply a misnomer. No patent claim has ever been directed to a gene, partly because the word “gene” itself has always been and will perhaps always be an indefinite word even to those skilled in the art. See, e.g., Helen Pearson, What Is A Gene?, 441 Nature 399 (2006). While the word “sequence” is used by many patent practitioners and appears in the preamble of many patent claims, the author of this Note takes the position that “sequence” refers only to the order in which nucleotides are arranged in a DNA molecule, and so it is the DNA molecule that should be the claimed subject matter, not any sequence. This basic concept must be understood first before analyzing the patent-eligibility of these claims.
[FN5] Ass’n for Molecular Pathology v. USPTO (Myriad), 702 F. Supp. 2d 181, 232 (S.D.N.Y. 2010).
[FN6] It appears that Judge Sweet thinks that “products of nature” encompass all patent-ineligible subject matter. See id. at 220 (“[T]he proper analysis requires determining . . . whether the claimed invention constitutes statutory subject matter . . . or whether the claimed invention instead falls within the judicially created ‘products of nature’ exception to patentable subject matter, i.e., ‘laws of nature, natural phenomenon, and abstract ideas,’ Chakrabarty, 447 U.S. at 309.”). The author of this Note takes the position that “product of nature” is but one judicially created category of patent-ineligible subject matter, if at all. For example, it is obvious that “product of nature” does not encompass “abstract ideas.”
[FN7] Id. at 227 (quoting Chakrabarty, 447 U.S. at 310).
[FN8] Id. at 229. “BRCA1” and “BRCA2” refer to the human breast cancer susceptibility genes 1 and 2, respectively.
[FN9] Id. at 218 n.40. In particular, the claim-in-suit in Chakrabarty is directed to a microorganism. The claims-in-suit in Gen. Elec. Co. v. De Forest Radio Co., 28 F.2d 641 (3d Cir. 1928), In re Marden, 47 F.2d 957 (C.C.P.A. 1931), and In re Marden, 47 F.2d 958 (C.C.P.A. 1931) are all directed to elements.
[FN10] These categories are by no means an exhaustive list of the subject matter that may appear in patent claims where the “product of nature” doctrine may be applied. The choice of these three categories for analysis is based on the available case law where subject matter patent-eligibility was or could have been discussed by the relevant authorities.
[FN11] U.S. Patent No. 1,082,933 p.9 l.120-21 (filed Jun. 19, 1912).
[FN12] See Gen. Elec. Co., 28 F.2d at 643.
[FN13] Myriad, 702 F. Supp. 2d at 219 n.40.
[FN14] Gen. Elec. Co., 28 F.2d at 642.
[FN15] “Discoveries” is explicitly written in the “IP Clause” of the Constitution. U.S. Const. art I, § 8, cl. 8.
[FN16] See, e.g., In re Marden, 47 F.2d 957, 1046 (C.C.P.A. 1931) (“Uranium is a product of nature, and the appellant is not entitled to a patent on the same, or upon any of the inherent natural qualities of that metal.”); In re Marden, 47 F.2d 958, 959 (C.C.P.A. 1931) (“[P]ure vanadium is not new in the inventive sense, and, it being a product of nature, no one is entitled to a monopoly of the same.”).
[FN17] Cochrane v. Badische Anilin & Soda Fabrik, 111 U.S. 293, 311 (1884) (“Artificial alizarine,” though “made artificially for the first time,” is “an old article” that could be “eliminated from the madder root,” and is not patentable as “a well-known substance.”). Judged by today’s standard, the claim-in-suit is a product-by-process claim and would have been novel over the same product produced by known methods. See Abbott Labs. v. Sandoz, Inc., 566 F.3d 1282 (Fed. Cir. 2009). Another often cited case is American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. 566 (1874). The product claim-in-suit in this case, however, is not directed to a molecule, but “a pulp suitable for the manufacture of paper.” Id. at 594. The claim was invalidated because the pulp was not novel. Were it novel, it “might have been patented.” Id. at 596. These two cases, as some of the most fervent proponents of the “product of nature” doctrine clearly stated, “were not really product of nature cases.” Conley & Makowski, Back to the Future (I), supra note 4, at 328 n.193.
[FN18] See, e.g., In re Williams, 171 F.2d 319 (C.C.P.A. 1948) (holding that laevo rotary form of lactone was patentable over the known racemic form); In re Bergstrom, 427 F.2d 1394 (C.C.P.A. 1970) (holding that purified prostaglandins PGE2 and PGE3 were not anticipated by those previously extracted from human or animal prostate glands). Another often cited case is Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y. 1911), holding that purified adrenaline in base form was not anticipated by the existence of adrenaline in suprarenal glands, because adrenaline in suprarenal glands exists as a natural salt, not in base form. Id. at 103. Yet another often cited case that is further removed from the “product of nature” doctrine is Farbenfabriken of Elberfeld Co v. Kuehmsted, 171 F. 887 (7th Cir. 1909) (holding that the claim directed to acetyl salicylic acid (“aspirin”), the product of a new process which for the first time produced it in a pure state and rendered it valuable for medicinal use, is valid and infringed), because aspirin is not a product of nature, but man-made. Id. at 890.
[FN19] See, e.g., In re Kratz, 592 F.2d 1169, 1172 (C.C.P.A. 1979). The “synthetically produced” limitation in the composition claim-in-suit would have brought the scope of the claim outside the ambit of “product of nature,” so that the doctrine would not have applied in this case in the first place. Judge Sweet agreed that Kratz was not attacked or discussed as a subject matter patent eligibility case, but did not make it clear whether it could have been attacked under the “product of nature” doctrine. Ass’n for Molecular Pathology v. USPTO (Myriad), 702 F. Supp. 2d 181, 227-28 (S.D.N.Y. 2010).
[FN20] Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156, 157, 164 (4th Cir. 1958); U.S. Patent No. 2,703,302 col.21, l.70 through col.22 l.6 (filed Dec. 8, 1952). The claims-in-suit are not really molecule claims, as evidenced by the highlighted plural form of “products.” The court also agreed that the claimed composition was not pure. Merck & Co., 253 F.2d at 160.
[FN21] Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F. 2d 1200, 1202, 1204, 1206 (Fed. Cir. 1991). To ensure consistency and to minimize confusion, the claim should have been drafted to be directed to a purified and isolated DNA molecule. See supra note 4.
[FN22] Schering Corp. v. Amgen Inc., 222 F.3d 1347 (Fed. Cir. 2000); Schering Corp. v. Amgen Inc., 18 F. Supp. 2d 372, 400 (D. Del. 1998).
[FN23] Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 128 n.1, 132 (1948).
[FN24] See id. at 128 n.1.
[FN25] See id. at 131 (“The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. . . . Their use in combination does not improve in any way their natural functioning.”). This language suggests that once the conditions expressed in the negative are met, the subject matter may be patent-eligible.
[FN26] A plasmid is a kind of DNA molecule.
[FN27] Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980).
[FN28] See supra note 25 and accompanying text.
[FN29] See supra notes 23-25 and accompanying text. Contra Conley & Makowski, Back to the Future (II), supra note 4, at 376.
[FN30] Chakrabarty, 447 U.S. at 310.
[FN31] Myriad, 702 F. Supp. 2d at 228-29 (“[DNAs] are physical carriers of information . . . . This informational quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different’ than other chemicals previously the subject of patents. Myriad’s argument that all chemical compounds . . . necessarily conveys [sic] some information ignores the biological realities of DNA in comparison to other chemical compounds in the body. The information encoded in DNA is not information about its own molecular structure incidental to its biological function . . . . Rather, the information encoded by DNA reflects its primary biological function: directing the synthesis of other molecules in the body – namely, proteins . . . .”) (second alteration in original) (emphasis in original) (footnote omitted) (citations omitted) (internal quotation marks omitted). While there is no doubt that DNA’s function as a carrier of genetic information is of great importance, this function is determined by its molecular structure. After all, the course that teaches DNA and the central dogma is called Molecular Biology, not Informational Biology. No molecular structure is incidental to the molecule’s biological function; the molecular structure at least in part determines the biological function. The biological function may be directing the synthesis of proteins, as in the case of DNA molecules, or binding some targets in the body, as in the case of many other biologically active chemical compounds. The ability of a certain chemical compound to bind some targets and not others is also information about other molecules in the body. Such information is the subject of study in the fields of chemoinformatics and pharmacoinformatics. Even though this information is not “genetic” information, it nevertheless is of great importance to our understanding of the human body.
[FN32] The laevo rotary form of a compound has the property of deflecting polarized light to the left, while the racemic form produces no deflection of polarized light. In re Williams, 171 F.2d 319 (C.C.P.A. 1948).
[FN33] In re Bergstrom, 427 F.2d 1394, 1398, 1402 (C.C.P.A. 1970).
[FN34] Id. at 1401.
[FN35] Conley & Makowski, Back to the Future (II), supra note 4, at 387-88.
[FN36] For example, pure tungsten has ductility and high tensile strength not observed in a tungsten compound. See supra note 11 and accompanying text.
[FN37] A chromosome is a naturally-occurring DNA molecule.
[FN38] U.S. Patent No. 5,747,282 (filed Jun. 7, 1995) (the “’282 Patent”) col.19 l.8-18; U.S. Patent No. 5,837,492 (filed Apr. 29, 1996) (the “’492 Patent”) col.17 l.62 through col.18 l.5 (emphasis added).
[FN39] Ass’n for Molecular Pathology v. USPTO (Myriad), 702 F. Supp. 2d 181, 230 (S.D.N.Y. 2010); ’282 Patent col.153 l.56-58 (“An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth set forth in SEQ ID NO:2.”); ’492 Patent col.167 l.16-19 (“An isolated DNA molecule coding for a BRCA2 polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2.”) (emphasis added).
[FN40] See Myriad, 702 F. Supp. 2d at 230-31 (quoting Myriad Defendants’ Memorandum in Reply to Plaintiffs’ Opposition to Myriad Defendants’ Motion for Summary Judgment at 9, Myriad, 702 F. Supp. 2d 181 (No. 109CV04515)).
[FN41] See supra notes 33-35 and accompanying text.